The position will handle the routine management & coordination of GMP compliance systems and policies for cGMP compliant facilities for bulk drug substance manufacturing.
Support of deviations, CAPA's and change controls and disposition as appropriate.
Monitors policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency guidelines to ensure lasting customer satisfaction.
Demonstrate high level of involvement in continuous improvement of quality assurance philosophy and practices to ensure the highest standards are maintained.
Examines programs to create efficiencies in practices and optimal utilization of staff. Review of production records for compliance. Assures cGMP's and company procedures are followed and, if needed, procedures/policies are revised.
Accountable for meeting functional area goals and objectives as they relate to departmental and company's goals. Responsible for adhering to GMP regulations, cGMP's, company policies, and DNA leadership capabilities.
Quality System management and improvement: 60 % Client consulting and guidance 40%
Education and Experience Requirements
. A minimum of a B.S. degree in science or engineering with at least 5 years relevant experience executing, developing, and/or administrating GMP quality programs in cGMP biotech and/or pharmaceutical environments. . Excellent interpersonal skills and the ability to communicate well orally and in writing.